EP1839583A1 - Device for temporary immobilisation of tissue near a pulsing blood vessel with blood flow - Google Patents

Abstract

The device has a base (30) that is attachable at a tissue over a contact surface. Intake openings that are present in the contact surface are joinable with a vacuum source. The base comprises a stiff retainer (63), which supports a flexible unit (66) in the contact surface. Flexibility of the unit (66) is formed, such that the contour of the unit (66) is arranged at a contour of tissue in the contact surface.

Description

The invention relates to a device for temporary immobilization of tissue in the region of a pulsating blood vessel, in particular a coronary vessel, during a cardiac and / or thorax surgery, with a foot which can be applied to the tissue via an abutment region, wherein there are suction openings in the abutment region are, which are connectable to a vacuum source.

Such a device is for example from the WO 02/28287 A1 known.

Such devices are used in cardiac and / or thorax surgical procedures in which the beating heart surgery on the coronary vessels are made. One of these techniques is the so-called MIDCAB (Minimally Invasive Direct Coronary Artery Bypass) technique. This technique is done via an intercostal space.

In another surgical technique, the sternum is severed lengthwise, and the rib cage is laterally spread over so-called rib blockers or retractors. For a better access to the heart is still raised one half of the chest, namely the left, opposite the right half of the chest. Now, beating heart surgery can be performed without connecting the heart to a heart-lung machine called OPCAB (Off Pump Coronary Artery Bypass).

For example, in beating heart surgery, a sternum artery, previously prepared accordingly, is sutured directly to a beating heart vessel to thereby bypass a coronary vessel obstruction or obstruction. Since, as mentioned above, the heart is still beating, so performing pulsating movements, it is very difficult to make an intervention at this point.

In order to immobilize or stabilize the tissue in the region of the vessel on which the bypass is to be laid, the devices mentioned at the outset, which are also called OPCAB stabilizers, have become established.

Such devices have a foot that can be applied to adjacent tissue on both sides of and alongside the vessel of the beating heart and thereby immobilize that region.

Depending on the embodiment of the foot is like a fork head formed with two approximately parallel to each other extending tines, which are created on both sides of the vessel can, or it consists, as in the publication mentioned above, of two individual components, which can each be applied to one side of the vessel. The foot or tine is connected to an arm, which in turn is connected to a stationary device, for example attached to a previously mentioned rib catcher. Thus, the foot can be applied to the tissue under a certain pressure and immobilized in the area to the left and right of the vessel on which the intervention must be made.

Intake openings are provided in the foot, via which the tissue can additionally be sucked in by a negative pressure on the foot, so that pulsating movements in this area can hardly take place and the surgeon finds a largely stationary, ie immobilized, surgical site.

Due to the fact that such interventions take place on one of the most important organs of life, the still beating heart, which, however, is severely impaired in its functioning owing to pathological changes, there is an endeavor to be able to adapt the foot as well as possible to the anatomical anomalies in the abutment area.

Therefore, in the aforementioned WO 02/28287 A1 and in particular in the WO 00/15119 A2 Numerous adjustment provided in the foot area, so that it can be adjusted with as many degrees of freedom. This includes a twisting, tilting and pivoting of the foot or the two prongs relative to each other. Although this makes it possible to adapt to specific orientations of the fabric, ultimately the fabric must always conform to the foot, which is made of stiff materials.

In the WO 00/15119 A2 is mentioned at one point to make the entire foot of a plastically deformable material, so that it can be bent in place by the surgeon in a certain orientation. However, it has to be then adjust the tissue this bent, for example, step-shaped foot.

From the US 6,074,375 a device for introducing a fluid into the heart muscle is known. The liquid is introduced with a kind of syringe into the muscle of the beating heart. To immobilize the tissue area at the puncture site for targeting, a bipedal suction foot is provided which can be applied to the heart muscle and through which a vacuum can be applied. Suction openings at the outer end of the two legs serve to suck in the tissue. The legs have flexible sections to conform to the contour of the heart surface. The legs remain in the bent orientation. A soft-elastic layer serves as a seal between the muscle surface and the outer end with the suction openings. Again, the tissue adapts to the shape of the foot.

From the DE 20 2004 012 637 U1 is a Saugstabilisator with a base body and attachable thereto, relatively hard suction known.

It is therefore an object of the present invention to provide a device of the type mentioned, which allows atraumatic immobilization of the tissue.

According to the invention the object is achieved in that the foot has a rigid holder which carries in the contact area a flexible element having the suction, wherein the flexibility is designed such that the contour of the flexible element adapts to the contour of the tissue in the investment area ,

The now proposed embodiment makes it possible on the one hand to accomplish a very specific spatial orientation of the foot relative to the tissue on the rigid holder, which is spatially immovable and which also ensures that a certain contact pressure can be exercised. By providing the flexible On the other hand, in the area of the abutment area it is possible for the foot in the abutment area in the region of the flexible element to adapt to the shape of the tissue to some extent, and not vice versa. For example, if there is a bump in the tissue in the abutment area, it may push into the flexible element, so that the contour of the flexible element adapts to the contour of the tissue in the abutment area. Since the suction openings are present in the flexible element, the suction openings lie exactly snugly against the fabric area, for example also on curved areas or on the aforementioned hump. If vacuum is applied to the suction openings, the tissue lying in the contact area is sucked in only for additional support, but is no longer deformed or changed in its entirety.

In other words, if, for example, a stiff rectilinear holder were applied to a region of tissue having the aforementioned hump, the hump would have to be pressed into the depths of the tissue. If this is to be prevented, the tissue, which in fact lies nearer or stronger to the abutment area in the area of the hump, would be sucked in more than in other areas, ie. In these areas, a relatively large deformation would take place upon application of the negative pressure.

This could lead, for example, to the fact that the surgeon first applied the foot very well aligned to the tissue without affecting the vacuum source, but after the application of the negative pressure, undesired changes in position or tissue displacements can take place.

This can largely be ruled out with the embodiment with the flexible element, since tissue and flexible element in the contact area adapt to each other, thus the flexible element can cling to the tissue or vice versa. The vacuum applied via the suction openings in the flexible element then no longer leads to larger tissue displacements, but merely to an additionally adhering fixation of the tissue on the foot. Thus, can a particularly atraumatic creation and immobilization of the tissue can be achieved, for example, on the beating heart.

In a further embodiment of the invention, the flexible element is releasably attached to the holder.

This measure has the advantage that depending on the anatomical conditions elements of different flexibility can be attached.

In a further embodiment of the invention, the holder is made of metallic material.

This measure has the advantage, in particular with the embodiment of the releasable attachability of the flexible element, that the holder is suitable for multiple use, that is, after an intervention after removal of the flexible element can be appropriately cleaned and sterilized.

For this purpose, it is provided in a further embodiment that the flexible element is designed as a disposable part for single use.

This measure has the advantage that after performing an operation, the flexible element is removed and discarded. The arm can be cleaned and sterilized in this state, ie without the flexible element, and a new flexible element is set up for a next procedure.

In a further embodiment of the invention, the flexible element is designed as a tubular element.

This measure has the advantage that the tube geometry, with selection of appropriate dimensions and materials, a high variability in the degree of flexibility of the element allows. At the same time can over the tubular Element to apply a negative pressure to achieve the additional fixation of the fabric to the tubular member.

In a further embodiment of the invention, the tubular element is connectable at one end with a suction nozzle of the holder.

This measure has the advantage that the aforementioned application of negative pressure is easily possible, namely by the tubular element being pushed onto a corresponding suction nozzle of the holder.

In a further embodiment of the invention, the flexible element comes to lie in the contact area at a distance from the holder.

This measure has the advantage that the flexible element can dodge or bulge laterally in order, for example, to be able to adapt to extreme bends or other anomalies in the area of the tissue. The fact that the flexible element is attached to a rigid holder, however, limits this deflection, so that the desired contact pressure can be exerted.

In a further embodiment of the invention, the holder is formed as a strip, projecting from the plant side at least one holding element, to which the flexible element is attachable.

This measure has the advantage that relatively much space is available on the contact side of the strip in order to provide the holding devices for the flexible element to which the flexible element is releasably or non-releasably attachable depending on the embodiment.

In a further embodiment of the invention, the tubular element is designed as a hose piece which can be pushed onto an intake nozzle at one end and slid onto a retaining pin at the other end.

This measure has the advantage that the tubular element is particularly cost-effective to manufacture, is particularly easy to handle and due to its geometry allows a particularly atraumatic application.

The corresponding piece of tubing, which is stocked, for example, by the meter with predetermined separation points or as a single piece, only needs to be pushed onto the two stubs, so that the device is ready for use.

In a further embodiment of the invention, the foot is designed as a fork head with two prongs, each prong being designed as a rigid holder with a flexible element attached thereto.

This measure has the advantage that the foot can be applied on both sides of the vessel to be immobilized in one operation by a single element and the foot is equipped on both sides with a flexible element, so that the entire foot can be placed on the tissue in a particularly atraumatic manner.

In a further embodiment of the invention, the suction openings are provided in the jacket of the hose piece.

This measure has the advantage that this is accomplished very simply by machine and the piece of tubing is available as a prepared, optionally sterile packaged replacement part.

In a further embodiment of the invention, the foot is attached to a bendable in all spatial directions and lockable in this bending arm.

This measure, which is known per se, has the advantage that the foot can be placed over the arm by the surgeon in an ergonomically favorable and easily accessible position for the operation and then determined in this position.

In a further embodiment of the invention, the arm is provided at the end opposite the foot with a holder, via which the arm can be fastened to a retractor.

This measure has the advantage that the device can be attached to a component which is present in any case during the operation, namely the retractor or the rib spreader which spreads the rib cage. This component is relatively stationary and serves as an abutment for the arm, so that the foot can be very easily brought by the surgeon in a specific spatial and stationary relative position to the retractor, the foot then comes to rest on the tissue.

It is understood that the features mentioned above and those yet to be explained below can be used not only in the particular combination given, but also in other combinations or in isolation, without departing from the scope of the present invention.

Fig. 1

eine perspektivische Darstellung einer erfindungsgemäßen Vorrichtung, die an einer Schiene eines Retraktors angebracht ist,

Fig. 2

eine perspektivische Detailansicht eines Fußes der Vorrichtung von Fig. 1 in einer teilweisen Explosionsdarstellung, also mit noch nicht angelegtem bzw. abgenommenem flexiblen Element,

Fig. 3

eine stark vergrößerte perspektivische Detailansicht des Fußes von Fig. 1,

Fig. 4

einen Schnitt längs der Linie IV-IV in Fig. 3 mit angeschlossener Vakuumleitung, und

Fig. 5

einen der Fig. 4 vergleichbaren Schnitt, wobei die Anpassung der Kontur des flexiblen Elements an die Kontur des Gewebes ersichtlich ist.

The invention will be described and explained in more detail below with reference to a selected embodiment in conjunction with the accompanying drawings.
Show it:

Fig. 1

a perspective view of a device according to the invention, which is attached to a rail of a retractor,

Fig. 2

1 shows a perspective detail view of a foot of the device of FIG. 1 in a partially exploded view, that is to say with the flexible element not yet applied or removed,

Fig. 3

a greatly enlarged perspective detail view of the foot of Fig. 1,

Fig. 4

a section along the line IV-IV in Fig. 3 with connected vacuum line, and

Fig. 5

one of the Fig. 4 comparable section, wherein the adaptation of the contour of the flexible element is visible to the contour of the fabric.

A device according to the invention shown in FIGS. 1 to 5 is indicated in its entirety by the reference numeral 10.

The device 10 has at one end a holder 12, via which the device 10 can be attached to a rail 14 of a retractor 16 or a rib spreader.

In this embodiment, the device 10 is thus a functional element of a retractor.

From the holder 12 projects an arm 18, which is designed as a so-called Leyla arm 20. Such a Leyla arm 20 is characterized in that it can be bent in all spatial directions and locked in such a bent position. For this purpose, such a Leyla arm 20 consists of individual articulated elements that allow these deflections. For locking a drawing wire is centrally present throughout, which is connected to a knob 22. As mentioned, with dissolved knob 22, the arm 18 can be changed in all directions. By tightening the knob remains the arm, for example, in the curved position shown in Fig. 1, immovably.

At its end opposite the adjusting knob 22, the arm is connected via a joint 24 to a foot 30.

The foot 30 is formed as a clevis 32, which has two mutually parallel tines 34 and 36 which are connected via a cross bar 38 with each other are. The clevis 32 is made of a strip 40 of a metallic material.

Each of the two prongs 34 and 36 has, starting from the cross bar 38, a first portion 42, which merges via a bend in a second portion 44, the extreme end passes approximately at right angles to a bent end portion 46.

From the inside 48 of the bent portion 46 is a conical pin 50 (see in particular Figs. 2 and 4).

The conical pin 50 has a neck 52 which is received in an opening not shown here in the bent portion 46.

From the bottom of each prong 34 and 36 is in the area after the cross bar 38 in each case an eyelet 54, in which a suction nozzle 56 is mounted.

The suction nozzle 56 has a first port 58 which is conical and which faces the conical pin 50.

On the opposite side of the eyelet 54 is a second port 60 before. In the suction nozzle 56 in the middle continuously extends a suction channel 62nd

On the other hand, a flexible element 66 in the form of a piece of tubing 58 can be pushed onto the conical pin 50 on the one hand or onto the first socket 58 on the other.

From the sectional view of Fig. 4 it can be seen that one end 70 of the hose piece 68 is pushed completely over the conical pin 50 and the neck 52, so there is taken tightly.

From the sectional view of Fig. 4 it can be seen that an undercut is created by the transition from the conical pin 50 to the cylindrical neck 52, over which the end 70 of the tube piece 68 must be pushed under widening, thereby preventing a peel.

The same applies to the opposite end 72 of the hose piece 68. This is pushed onto the first port 58 of the suction nozzle 56 accordingly captive.

In particular, from the sectional view of FIG. 4 it can be seen that each of the tines 34 and 36 is formed in connection with the conical pin 50 and the first port 58 as a rigid holder 63, which serves as a holder for the flexible member 66.

The tube piece 68 consists of a silicone tube, in the wall of which five suction openings 74 to 78 are recessed on one side (see in particular FIG. 2).

The piece of tubing 68 is selected to have flexibility in the portion between pin 50 and stud 58 but is still dimensionally stable so that it will not collapse on a vacuum applied inside tubing 68.

As can be seen from Fig. 5, a vacuum line 84 is pushed onto the second port 60, which is connected to a vacuum source.

In practical use, the device 10 is applied, for example, to a coronary vessel such that a portion of this vessel extends parallel and between the two prongs 34 and 36. For this purpose, the device 10 or its foot 30 in a contact region 64 which extends approximately over the length of the tube piece 68, applied to a corresponding tissue 80 on both sides of the lying between the tines 34 and 36 blood vessel.

If, for example, a bump 82 is present in this area, the flexible element 66 can adapt to the curvature of the bump 82 to a certain extent due to the flexibility of the hose piece 68. As a result, the five intake openings 74, 75, 76, 77 and 78 then also conform to the fabric 80 in a uniform manner. It can be seen from FIG. 4 that the hump 82 will initially only come into contact with the suction opening 76, the suction openings 75 and 77 would come to rest at a certain distance from the fabric 80 on both sides, and the end-side suction openings 74 and 78 would still be at a considerable distance to lying.

Due to the flexibility of the tube piece 68, this flexible tube piece 68 can atraumatically adapt to the geometry of the tissue 80, as can be seen from FIG. 5.

Due to the stiff holder 63, however, a sufficient contact pressure can still be exerted by the tube piece 68 in order to immobilize the tissue 80 in this area.

By applying a negative pressure via the vacuum line 84, the tissue 80 can be additionally fixed to the piece of tubing 68 and thus also immobilized simultaneously, which is also atraumatic, since previously the tube portions with the suction 74 to 78 already nestled against the fabric 80 to have.

After the procedure, the tube piece 68 only needs to be removed from the pin 50 or the socket 58 and can be discarded, so that the foot 30 or its metallic components can then be subjected to cleaning and sterilization.

For a further engagement, a new piece of tubing 68 is then attached to the underside of each prong 34 and 36 so that the device 10 is ready for re-engagement.

Claims (13)

Device for temporary immobilization of tissue (80) in the region of a pulsating blood vessel, in particular a coronary vessel, during cardiac and / or thorax surgery,
with a foot (30) which can be applied to the fabric (80) via an abutment region (64), wherein in the abutment region (64) there are suction openings (74 to 78) which can be connected to a vacuum source,
characterized in that
the foot (30) has a rigid holder (63) which carries in the abutment region (64) a flexible element (66) having the suction openings (74-78), the flexibility being such that the contour of the flexible one Element (66) to the contour of the fabric (80) in the contact area (64) adapts. Apparatus according to claim 1, characterized in that the flexible element (66) is releasably attached to the holder (63). Apparatus according to claim 1 or 2, characterized in that the holder (63) is made of metallic material. Device according to one of claims 1 to 3, characterized in that the flexible element (66) is designed as a disposable part for single use. Device according to one of claims 1 to 4, characterized in that the flexible element is designed as a tubular element (66). Apparatus according to claim 5, characterized in that the tubular element (66) at one end (72) with a suction nozzle (56) of the holder (63) is connectable. Device according to one of claims 1 to 6, characterized in that the flexible element (66) comes to lie in the contact region (64) at a distance from the holder (63). Device according to one of claims 1 to 7, characterized in that the holder (63) as a strip (40) is formed, from the plant side at least one holding element (50, 58) protrudes, to which the flexible element (66) is attachable. Device according to one of claims 1 to 8, characterized in that the tubular element (66) as a hose piece (68) is formed, which at one end (72) on a suction nozzle (56) can be pushed and at the other end (70) a holding pin (50) can be pushed. Device according to one of claims 1 to 9, characterized in that the foot (30) has a clevis (32) with two prongs (34, 36), each prong (34, 36) being a rigid holder (63) with one thereon attached flexible element (66) is formed. Apparatus according to claim 9 or 10, characterized in that in a jacket of the hose piece (68), the suction openings (74-78) are provided. Device according to one of claims 1 to 11, characterized in that the foot (30) is attached to a bendable in all spatial directions and lockable in these bending positions arm (18). Apparatus according to claim 12, characterized in that the arm (18) is provided at the end opposite the foot (30) with a holder (12) through which the arm (18) to a retractor (16) can be fastened.

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